Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination Among Women Attending Preventive Oncology Clinic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01271673
First received: January 6, 2011
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

Breast cancer is the most common cancer among women residing in majority of the urban areas in India. The deaths due to breast cancer are mainly a result of late presentation of the symptoms due to lack of awareness of the signs and symptoms of the disease and lack of knowledge of performing BSE. The BSE technique can be a good tool for improving the awareness about the symptoms of breast cancer. Hence, we propose a pilot study of short duration (3 months follow-up), to assess the level of compliance to BSE and assess the various reasons for non-compliance. Based on the results of this study a long term cohort study will be planned with similar objectives.


Condition
Breast Self Examination

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Short Duration Pilot Cohort Study to Assess the Level of Compliance in Undertaking Breast Self Examination (BSE) Among Women Attending Preventive Oncology Clinic

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Compliance to Breast Self Examination [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To assess the level of compliance in undertaking Breast Self Examination among women attending Preventive Oncology Clinic.


Secondary Outcome Measures:
  • Association of various socio-demographic factors and the level of compliance to Breast Self Examination [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To study the association of various socio-demographic factors and level of compliance with Breast Self Examination.


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women undertaking Breast Self Examination
Women attending Preventive Oncology Clinic during the month of November- December 2010,and undertaking BSE training whose Residential address mentioned as Mumbai and whose Contact number is available.

Detailed Description:

This is an observational cohort study about BSE among women attending the Preventive Oncology (PO) Clinic, TMH. All women attending for screening of common cancers at the Preventive Oncology OPD at TMH are demonstrated the technique of BSE and advised on when, how and why to perform BSE.

Women attending the PO clinic and who have mentioned their residential address as Mumbai and provided contact number will be invited to participate in the study. They will be explained the study protocol and those who are interested in participating will be offered informed consent forms. The women who sign the informed consent form will be enrolled into the trial.

The data regarding the socio-demographic details and level of knowledge, attitude and practice (KAP) about breast cancer and BSE will be collected from the participating women. They will be asked if they have any doubts regarding the technique of BSE and their willingness to perform BSE. Thereafter, a follow-up period of 3 months, the women will be contacted telephonically to collect the data to assess the level of compliance to BSE and the reasons for non-compliance, if any. Also, the compliant women will be asked if they have observed any abnormal changes in their breasts and have they visited the clinician for the same. And subsequently, their health care seeking behaviour will be studied.

The data collected before and after the follow-up will be entered in the SPSS software and analyzed using simple statistical tests like mean, chi-square, t-test and univariate and multivariate analysis.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women attending Preventive Oncology Clinic in the month of November-December 2010.

Criteria

Inclusion Criteria:

  • Women attending Preventive Oncology Clinic during the month of November-December 2010.
  • Women undertaking BSE training.
  • Residential address mentioned as Mumbai.
  • Contact number available.

Exclusion Criteria:

  • Women residing outside Mumbai, Maharashtra.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271673

Contacts
Contact: Ketaki G Karnik, MSc +91-9920493177 ketakikarnik88@gmial.com
Contact: Gauravi A Mishra, MD +91-22-24157532 gauravi2005@yahoo.co.in

Locations
India
Department of Preventive Oncology, Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Ketaki G Karnik, MSc Health Sciences    +91-9920493177    ketakikarnik88@gmail.com   
Contact: Gauravi A Mishra, MD    +91-22-24157532    gauravi2005@yahoo.co.in   
Principal Investigator: Ketaki G Karnik, MSc Health Sciences         
Principal Investigator: Gauravi A Mishra, MD         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Ketaki G Karnik, MSc University of Pune
Principal Investigator: Gauravi A Mishra, MD Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01271673     History of Changes
Other Study ID Numbers: 827
Study First Received: January 6, 2011
Last Updated: January 6, 2011
Health Authority: India: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014